[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Pages 4564-4565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01170]



[EPA-HQ-OPP-2014-0805; FRL-9920-16]

EPA Proposal To Improve Corn Rootworm Resistance Management; 
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: EPA is making available for public comment a proposal to 
improve the corn rootworm insect resistance management program 
currently in place for registrations of plant-incorporated protectants 
(PIP) derived from Bacillus thuringiensis (Bt) in corn.
    EPA is also soliciting input from all affected stakeholders 
including corn growers, industry, academia, and the general public.

DATES: Comments must be received on or before March 16, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2014-0805, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].


I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a 
registrant or manufacturer of PIPs for control of corn rootworm, grow 
corn rootworm-protected corn PIPs for crop or animal production, serve 
as a corn agronomist, crop consultant or extension specialist, or 
conduct insect resistance management-related research. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this document applies to them. Potentially 
affected entities may include:
     Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the agency taking?

    EPA is making available for public comment a proposal to improve 
the corn rootworm insect resistance management program currently in 
place for registrations of plant-incorporated protectants (PIP) derived 
from Bacillus thuringiensis (Bt) in corn. EPA's proposal contains 
measures designed to delay corn rootworms' development of

[[Page 4565]]

resistance to Bt microbial pesticides genetically engineered into corn. 
This proposal responds to reports of widespread corn rootworm 
resistance to two Bt corn traits and reflects advice received by the 
Agency from the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) Scientific Advisory Panel (SAP). EPA believes that the proposed 
enhancements would prolong the effectiveness of Bt PIPs for corn 
rootworm control significantly--which is important because of the long 
safety record of these PIPs. If used properly, PIPs greatly reduce the 
need for conventional pesticides and the risks they may present to 
human health and the environment. EPA is soliciting input from all 
affected stakeholders including corn growers, industry, academia, and 
the general public.
    A copy of the proposal, entitled ``EPA Framework for PIP 
Registrants: Proposal to Address Key SAP Recommendations for Corn 
Rootworm (CRW) IRM,'' is available in the docket.
    As part of its regulation of insect resistance management for Bt 
PIPs, EPA requires a resistance monitoring program for the major target 
pests of corn and cotton. The primary objective of resistance 
monitoring is to detect shifts in susceptibility before the onset of 
resistance leads to widespread field failure. Specific resistance 
monitoring strategies have consisted of two main components:
    1. Investigation of unexpected field damage reports from growers, 
extension agents, consultants, or company agronomists, and
    2. Monitoring for changes in susceptibility through targeted 
population sampling and testing.
    For both objectives, bioassays are used to determine the 
susceptibility of each sampled population. If resistance is detected in 
the assays, a remedial action plan is triggered with the goal of 
containing the resistant population to maintain trait durability.
    CRW presents a number of challenges for resistance monitoring. The 
insect has one generation per year, undergoes obligate diapause, and 
feeds subterraneanly--factors that limit the ability to conduct 
susceptibility bioassays. CRW are generally less sensitive to Bt toxins 
than other target pests of Bt PIPs (e.g., lepidoptera). To illustrate, 
all of the Bt toxins registered for CRW control (Cry3Bb1, Cry34/35, 
mCry3A, and eCry3.1Ab) are not considered ``high dose'' (as defined by 
EPA's 1998 FIFRA SAP), meaning that some susceptible CRW individuals 
will likely survive exposure to Bt. These factors can complicate both 
field scouting and interpretation of bioassays. Timing is also a 
concern; because of obligate diapause, a sampled population may not be 
tested (and determined to be resistant) until the following season.
    EPA is concerned about the ability of CRW to develop resistance to 
Bt corn PIPs. Recent reports have documented CRW resistance to two Bt 
traits, Cry3Bb1 and mCry3A, in parts of Iowa and Illinois. Seeking 
guidance in regards to these concerns, the Agency convened a FIFRA SAP 
meeting in December 2013. The panel was tasked with evaluating EPA's 
current resistance monitoring strategy for CRW and providing 
recommendations for improvement. Meeting materials, including a white 
paper detailing EPA's concerns with CRW resistance monitoring, the 
charge to the SAP, and the SAP's final report, are available in docket 
number EPA-HQ-OPP-2013-0490.
    Following the SAP meeting, EPA developed the mitigation proposal to 
enhance CRW resistance management. EPA's proposed enhancements address 
the following five aspects of CRW resistance management:
     Integrated Pest Management (IPM) as a component of corn 
rootworm resistance management.
     Responses to unexpected damage in Bt corn fields.
     Elimination of the requirement for annual random sampling 
of corn rootworm from the Corn Belt.
     Use of on-plant assays for resistance determinations.
     Enhancements to current remedial action plans.
    EPA believes that these proposed enhancements are consistent with 
the SAP's guidance and will prolong the effectiveness of Bt corn PIPs 
for CRW control by reducing selection pressure for resistance, 
improving resistance detection capability, and better mitigate 
populations that do develop resistance. The Agency's goals are to 
prolong the durability of Bt corn while maintaining the environmental 
benefits of these important CRW management tools.
    The Agency is seeking input on the proposal from potentially 
affected entities and other stakeholders, including (but not limited 
to) registrants of pesticides and PIPs for corn, corn growers, crop 
consultants/agronomists, commodity groups, extension entomologists, 
independent researchers, and the general public. Commenters are also 
encouraged to provide input on the specific recommendations provided by 
the SAP, including alternate approaches or counter proposals towards 
addressing the CRW resistance management issues raised by the panel.

    Authority: 7 U.S.C. 136 et seq.

    Dated: December 31, 2014.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 2015-01170 Filed 1-27-15; 8:45 am]